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Kidney Week

Abstract: PO0582

The Efficacy and Safety of Denosumab for Osteoporosis in Advanced CKD with or Without Dialysis

Session Information

Category: Bone and Mineral Metabolism

  • 402 Bone and Mineral Metabolism: Clinical

Authors

  • Cho, Illeon, Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Korea (the Republic of)
  • An, Jung Nam, Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Korea (the Republic of)
  • Song, Young rim, Hallym University Sacred Heart Hospital, Anyang, Gyeonggi-do, Korea (the Republic of)
Background

Chronic kidney disease (CKD) is associated with an increased risk of osteoporosis and fragility fractures. However, studies assessing the optimal risk stratifications and treatments for osteoporosis in patients with advanced CKD are limited. This retrospective analysis evaluated the efficacy and safety of denosumab in patients with CKD and those on dialysis using data from a single-center

Methods

A total of 96 CKD patients with or without dialysis (CKD stages G3-G5D) in our hospital, who had osteoporosis diagnosed by dual-energy X-ray absorptiometry and received denosumab 60mg subcutaneously every 6 months at least twice, were enrolled. Annual changes in bone mineral density (BMD), annual incidence rate of new fractures (vertebral or non-vertebral) and adverse events focused on hypocalcemia were the major outcomes. The subjects were classified into non-dialysis dependent or dialysis-dependent CKD (NDD-CKD or DD-CKD) groups.

Results

The annual changes in BMD (T-score) at the lumbar spine from baseline were significantly increased in both groups. The annual changes in BMD at the total hip and femoral neck were increased in both groups, although only the DD-CKD group showed significantly improved changes (Figure 1). The annual incidence rate of new fractures was similar (4.7 % for DD-CKD vs. 7.5 % for NDD-CKD, p = 0.688). The incidence rate of severe hypocalcemia was comparable between both groups (2.3 % vs. 0.0 %, p = 0.448), whereas those of mild to moderate hypocalcemia were significantly higher in DD-CKD (25.6 % vs. 1.9 %, p = 0.000; 20.9 % vs. 1.9 %, p = 0.005). None required hospitalization due to severe symptoms such as tetany and seizure.

Conclusion

Denosumab significantly increased BMD and was safe in advanced CKD patients with osteoporosis. Although severe hypocalcemia or other severe adverse outcomes were rare, physicians should keep in mind that the patients essentially need adequate vitamin D and calcium replacement prior to administration of denosumab.